Biomedical Quality Engineer

3 weeks ago

Irvine, United States Infosoft, Inc. Full time

Job Title: Biomedical Quality Engineer

Pay Rate: $40 to $44.98/HR

Duration: 3 months

Location: Orange County, CA

Our Client is a Global medical device Manufacturer.


We are looking for Biomedical Quality Engineer I


Description:

  • This position will be in THV Quality Engineering, Global Product Surveillance (GPS).
  • The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices.
  • Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and our systems/procedures for device investigation and risk assessments of reported complaints from the field.


Responsibilities:

  • Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
  • Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause
  • Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
  • Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determined by the investigation.
  • Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.
  • Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).


Education and Experience:

  • Bachelor's degree in engineering, 0 - 2 years experience related work experience required
  • Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
  • Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.


Additional Skills:

  • Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
  • Basic understanding of statistical techniques
  • Previous experience working with lab/industrial equipment required
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Solid problem-solving, organizational, analytical, and critical thinking skills
  • Solid understanding of processes and equipment used in assigned work
  • Knowledge of and adherence to Quality systems
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including the ability to manage project stakeholders
  • Ability to build productive internal/external working relationships

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